LAWRENCE — Though it may sound like science fiction, the day is coming when a TV’s pixels are light-emitting yeast organisms, or antibodies can be designed from scratch to seek out and kill cancer cells while leaving healthy cells untouched. When science has the capability of building new genes, cells and life forms from scratch, it’s natural there will be concern about the legal and ethical implications. A University of Kansas professor was commissioned by the National Academies to study the field of synthetic biology and recommend how the law should deal with the rapidly evolving science in the years to come.

Andrew Torrance, professor of law at KU, visiting scholar at the Massachusetts Institute of Technology and fellow of the Gruter Institute, was asked to prepare a report on synthetic biology, standards setting and intellectual property by the National Academies, an independent, nonprofit organization that provides expert advice to Congress and others on science, engineering and medicine. Torrance asked Linda Kahl, a SynBERC Fellow at Stanford University, to co-author the report. Torrance presented their findings at the National Academies headquarters in Washington, D.C., at the beginning of October. The report will inform the National Academies’ larger study on the topic and is available for free online.

Synthetic biology is a branch of science which, in essence, redesigns biological components or constructs new life forms, DNA and cells that don’t exist naturally.

“There have been a number of notable successes in this field,” Torrance said. “A poster child of the field is an artificial version of a compound used to make artemisinin, a complex chemical that can be an effective treatment for malaria. Although synthetic biology sounds like science fiction, as a field it’s already science fact.”

The science has the potential to engineer genes and cells from scratch with many implications for health, such as the ability to fight diseases, the efficient generation of biofuels and methods of industrial production. However, synthetic biology is a “dual use” technology, with potential to be used for beneficial or for nefarious purposes, such as bioterrorism. The National Academies asked Torrance to assess if the young science is generating standards for the structure and function of its products, if patents or other intellectual property protections might be harming the field’s progress and if current biosecurity standards are stringent enough to prevent dangerous biological products from falling into the hands of those who might use them as weapons.

Standards can be crucial to the success of a new technology. Torrance offers an example of Lego bricks. Pieces of Lego may come in many shapes and sizes, and can be used to build almost any structure, but they all share common connectors where they can plug into each other. The question of standards is more complex in synthetic biology, but many scientists in the field have proposed structural, functional or biosecurity standards intended to ensure the interchangeability and interoperability of basic genetic building blocks. One organization, the BioBricks Foundation, has even proposed that such building blocks be named “Biobricks.”

“There is considerable interest in knowing if the field has progressed to the point where everyone can agree on a set of beneficial standards,” Torrance said. “If done right, standards can encourage open innovation, in which it is easy for many people — even amateurs — to participate in the field. A well-governed standards setting process can ensure that no single party can use its patents to dominate others. A prevailing ethos in synthetic biology is democratizing biology and welcoming many into the field to promote better and faster innovation.”

In the report, Torrance and his co-author comprehensively examined the standards proposed for synthetic biology and considered existing law and policies on patents, trade secrecy, copyright and trademark as they apply to genes, both natural and synthetic. Numerous parties already hold patents covering technologies that could potentially be designated as standards. Torrance has previously published an analysis of the thousands of patents that already claim aspects of human genes, as well as experimental studies suggesting that strong patent rights can substantially affect rates of technological innovation, and his results have convinced him that it is important to get synthetic biology policy right.

“Poorly designed laws and premature standards could stunt the development of this exciting and valuable field,” he said. “As the fact that the National Academies have taken an interest indicates, it is crucial that we both understand what roles standards setting and intellectual property currently play in synthetic biology and that we ensure that they foster innovation in the field that benefits society.”

Interest in the field is growing rapidly, and is becoming more widely available to the public. Evidence of the explosion in popularity can be found in events like the iGEM Competition, in which thousands of competitors are given a kit of standard biological parts from the Registry of Standard Biological Parts. The iGEM teams use the parts, along with new parts of their own creation, to build new biological systems that operate in living cells.

One of Torrance’s longstanding interests is the patentability of biotechnology inventions. His report, as well as his other publications on gene patents, describes the ongoing and always controversial legal debate on whether genes can be patented. Court decisions have been rendered both for and against the practice, and the Supreme Court appears likely to decide the issue in the near future.

“Since 2005 the trend has been for courts to make it more difficult to patent genes plucked from human cells,” Torrance said.

However, synthetic DNA sequences deliberately designed by humans are likely to remain patentable, the authors concluded. They advised the National Academies to continue to monitor standards setting and intellectual property questions as they apply to synthetic biology and observed that, despite “considerable emphasis on standards setting,” only one standard — in biosecurity — has been widely adopted.

“Synthetic biology has enjoyed considerable enthusiasm for adopting standards, and many standards have been proposed,” Torrance said. “However, it may be too early in the development of the field for definitive standards. Premature standardization can force a field down an unproductive pathway, and standards are difficult to establish when the rate of technological innovation is rapid. What appears to be a useful standard one day may become obsolete the next. Even so, standards setting can play valuable roles if done correctly and at the right time in the evolution of a technology. All this early thinking about standards in synthetic biology may benefit the field in the future. It will be fascinating to see how this exciting field evolves.”

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